Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1. Model #455011202691 for Computed Tomography (CT
FDA device recall Z-1568-2009 · posted 2009-07-06 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Philips Healthcare has decided to recall the Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1 due to the fact that when images are saved or filmed that contain the Curved Multi-planar Reformation Section (cMPRS) views that were created with a short curve the Right/Left annotations will be reversed.
- Action taken
- An "URGENT - Field Safety Notice" dated April 27, 2009 was sent to all consignees via certified mail. The letter described the affected products, issue, and actions for the customer/user. The notification letter provides a work around until the new software is available. For further information or support concerning this issue, please contact your local Philips representative: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology) or to your local Philips Healthcare office.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 417 units
- Distribution
- Worldwide Distribution -- US including DC (states of AL, AR, AZ, CO, DC, FL, IL, KY, LA, MA. ME, MI, MN, MO, NJ, NY, OH, OR, PA, SC, TN, TX, VT, and WI) and countries of Africa, Albania, Austria, Aust
- Date initiated
- 2009-04-27
- Date posted
- 2009-07-06
- Date terminated
- 2012-09-21
- Location
- Cleveland, OH
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